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Clinical Trials/NCT03890835
NCT03890835
Unknown
Not Applicable

Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial

Cairo University0 sites70 target enrollmentMay 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Symptomatic Irreversible Pulpitis
Sponsor
Cairo University
Enrollment
70
Primary Endpoint
Postoperative pain after 6 hours postoperatively
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.

Detailed Description

* Patients will be clinically and radiographically examined and their eligibility will be assessed. * Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA). * After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA * The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken. * The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times. * The patients will be recalled after 6 and 12 months post-operatively.

Registry
clinicaltrials.gov
Start Date
May 2019
End Date
May 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Youssef Andraws

Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients aging between 18-40 years old
  • Patients with symptomatic irreversible pulpitis.
  • Radiographically: Absence or slight widening in periodontal ligament space.
  • Systemically- healthy patients (ASA I or II).
  • Patients who agree to attend for recall appointments and provide written consent.

Exclusion Criteria

  • Severe marginal periodontitis.
  • Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.
  • Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.

Outcomes

Primary Outcomes

Postoperative pain after 6 hours postoperatively

Time Frame: 6 hours postoperatively

Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"

Postoperative pain after 12 hours postoperatively

Time Frame: 12 hours postoperatively

Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"

Postoperative pain after 24 hours postoperatively

Time Frame: 24 hours postoperatively

Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"

Secondary Outcomes

  • Overall (clinical and radiographic) success after 6 months postoperatively.(6 months postoperatively)
  • Overall (clinical and radiographic) success after 12 months postoperatively.(12 months postoperatively)

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